BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE STANDARD TAPER ADAPTER

    MDR report key: 6414575 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01703
    Event Type
    Injury
    Date Received
    March 17, 2017
    Report Date
    July 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) # - (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: LOT: DESCRIPTION: A 113632, 493410, COMPREHENSIVE PRIMARY STEM 12MM MINI. A 113053, 550880, COMPREHENSIVE MODULAR HEAD 50X21X57. A 113956, 646490, HYBRID GLENOID BASE LARGE 4MM. PT-113950, 286110, POROUS TITANIUM HYBRID GLEN POST REGENEREX. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-01702 / 01704, 01706 & 01708.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED, HOWEVER, INFORMATION WAS RECEIVED THAT THE PATIENT DOES HEAVY LIFTING AT WORK WHICH MAY HAVE BEEN A CONTRIBUTING CONDITION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY. CLINICAL FOLLOW-UP SIX WEEKS POST-OP, REPORTED PATIENT EXPERIENCED PAIN, MILD SUPRASPINATUS AND GREATER TUBEROSITY TENDERNESS, TRICEPS TENDERNESS, AND IMPINGEMENT. SUBSEQUENTLY, ERYTHEMA WAS OBSERVED AT THE PROXIMAL ASPECT OF THE INCISION THIRTY-TWO DAYS POST-OPERATIVELY, AND WAS REPORTED TO HAVE RESOLVED AFTER FORTY-FIVE DAYS. CLINICAL FOLLOW-UP THREE MONTHS POST-OP REPORTED PATIENT EXPERIENCED INSTABILITY, ONGOING PAIN, AND MILD INCISION TENDERNESS. CLINICAL FOLLOW-UP APPROXIMATELY ONE YEAR POST-OP REPORTED THE PATIENT EXPERIENCED BICEP AND DELTOPECTORAL TENDERNESS, ONGOING PAIN, AND HETEROTOPIC OSSIFICATION FORMATION. THERE HAS BEEN NO REVISION REPORTED TO DATE, AND NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195316 COMPREHENSIVE STANDARD TAPER ADAPTER PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 470680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other